Investigator-Sponsored Protocol - Continued Use of Ibalizumab

This study has been completed.

Sponsor:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT01056393

First Posted: January 26, 2010

Last Update Posted: August 16, 2017

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Laboratory testing that includes routine HIV-1 viral load and CD4+ cell counts will be completed to assess the continued benefit of ibalizumab to the patient's HIV treatment. [ Time Frame: Every two months ]

Ibalizumab is to be administered to HIV-infected patients that have responded (defined as a minimum 0.7 log10 decline in HIV-1 viral load from TMB-202 Baseline) on the TMB-202 protocol. In addition to the investigator-selected Optimized Background Regimen, patient(s) will continue to receive the TMB-202 randomized dose of ibalizumab in open-labeled fashion (800mg IV every two weeks or 2000mg IV every four weeks) as per their original drug assignment for the TMB-202 protocol.

Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 800mg q2weeks, or 2000mg q4weeks.

Other Names:

TNX-355

TMB-355

Study Arms

Experimental: 800mg Q2Weeks

Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen

Intervention: Drug: ibalizumab

Experimental: 2000mg Q4Weeks

Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen

Intervention: Drug: ibalizumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Have had at least a 0.7 log10 decline in HIV-1 RNA from baseline at Week 16 and beyond while in TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure

Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason

Are able and willing to comply with all protocol requirements and procedures

Are 18 years of age or older

If sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug.

Exclusion Criteria:

Any active AIDS-defining illness per Category C except for cutaneous Kaposi's sarcoma and wasting due to HIV

Any significant disease (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study

Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations

Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects